Microsoft Word - Draft OMB Meeting Agenda-April 11 2019

dPOD CP f 95% CI g ERP Use Only OMB Meeting 4-11-2019 Pre-read Materials

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3.01 (1.31, 6.89) 5 5 1.00 0.57, 1.00 5 1.00 0.57, 1.00 0.00 -0.43, 0.43 dPOD CP f 95% CI g

Naturally Contaminated 28 Hours 1.91 (1.23, 3.80) 20 17 0.85 0.64, 0.95 17 0.85 0.64, 0.95 0.00 -0.23, 0.23 Matrix Strain Analysis Time Point MPN a / dPOD CP f 95% CI g x c POD CP d 95% CI X POD CC e 95% CI Presumptive Confirmed

Naturally Contaminated 28 Hours 1.12 (0.68, 1.91) 20 10 0.50 0.30, 0.70 10 0.50 0.30, 0.70 0.00 -0.28, 0.28 Matrix Strain Analysis Time Point MPN a / dPOD CP f 95% CI g x c POD CP d 95% CI X POD CC e 95% CI Presumptive Confirmed

dPOD CP f 95% CI g

- 5 0 0.00 0.00, 0.43 0 0.00 0.00, 0.43 0.00 -0.43, 0.43

- 5 0 0.00 0.00, 0.43 0 0.00 0.00, 0.43 0.00 -0.43, 0.43 7 20 10 0.50 0.30, 0.70 10 0.50 0.30, 0.70 0.00 -0.28, 0.28 MPN a / Test Portion N b Presumptive Confirmed x c POD CP d 95% CI X POD CC e 95% CI - 5 0 0.00 0.00, 0.43 0 0.00 0.00, 0.43 0.00 -0.43, 0.43 4.38 (1.72, 11.15) 5 5 1.00 0.57, 1.00 5 1.00 0.57, 1.00 0.00 -0.43, 0.43 AOAC Research Institute 0.59 (0.33, 0.97) 20 7 0.35 0.18, 0.57 7 0.35 0.18, 0.57 0.00 -0.28, 0.28 55 5 5 1.00 0.57, 1.00 5 1.00 0.57, 1.00 0.00 -0.43, 0.43

0.49 (0.25, 0.85) 20 8 0.40 0.22, 0.61 8 0.40 0.22, 0.61 0.00 -0.28, 0.28

OMA ERP - June 2016

MPN a / Test Portion N b Presumptive Confirmed x c POD CP d 95% CI X POD CC e 95% CI

MPN a / Test Portion N b Presumptive Confirmed x c POD CP d 95% CI X POD CC e 95% CI

OMAMAN-30 D/ PTM Validation Report 081501

Test Portion N b

Test Portion N b

Table 13: 3M ™ MDA 2 Listeriamonocytogenes Assay, Presumptive vs. Confirmed – POD Results (INDEPENDENT STUDY) Matrix Strain Analysis Time Point Deli Turkey (125 g) L. monocytogenes ATCC 19116 24 Hours Matrix Strain Analysis Time Point Raw Chicken Leg Pieces (25 g): Lot 1 Raw Chicken Leg Pieces (25 g): Lot 2 Whole Melon L. monocytogenes FSL J1-049 24 Hours Matrix Strain Analysis Time Point

Expert Review Panel Use Only

L. monocytogenes ATCC 19114 24 Hours

a MPN = Most Probable Number is calculated using the LCF MPN calculator provided by AOAC RI, with 95% confidence interval b N = Number of test portions c x = Number of positive test portions d POD CP = Candidate method presumptive positive outcomes divided by the total number of trials e POD CC = Candidate method confirmed positive outcomes divided by the total number of trials f dPOD CP = Difference between the candidate method presumptive result and candidate method confirmed result POD values

Vanilla Ice Cream (25 g)

g 95% CI = If the confidence interval of a dPOD does not contain zero, then the difference is statistically significant at the 5% level

04/05/2019